What are the responsibilities and job description for the Quality Engineer - NCR & Compliance position at TekOne IT Services Pvt. Ltd.?
Role: Operations Quality Engg
Location: Austin, TX - 78759
Duration: 6 Months on W2 (Possible extension)
Shift Timings: 8 am to 6 pm
Location: Austin, TX - 78759
Duration: 6 Months on W2 (Possible extension)
Shift Timings: 8 am to 6 pm
- 100% Onsite role.
- The role involves operations quality engineering with a focus on nonconformance management and general OPS quality functions.
- The candidate will support best practices, audit readiness activities, and ensure compliance across production areas.
- Quality systems expertise, particularly in nonconformance and CAPA.
- Strong technical writing skills, including reviewing and approving technical documents.
- Understanding of regulatory body regulations.
- Ability to work independently with strong critical thinking and communication skills to influence and drive solutions.
- Experience in technical writing and documentation tools may be beneficial.
- Day-to-day Responsibilities: Managing nonconformance issues and supporting general OPS quality functions; Engaging in audit readiness activities and ensuring best practices in quality and compliance; Working closely with TPM to meet quality standards, including reviewing and assisting with technical writing.
- Bachelor’s degree in STEM (Science, Technology, Engineering, Mathematics) required.
- 3 to 5 years of industry experience in quality engineering, ideally in medical devices, pharmaceuticals, or a related field.
- Experience in high-volume manufacturing, especially in an automated environment.
- Strong critical thinking, independent working capability, and effective communication skills.
- Quality systems experience, nonconformance management, CAPA, and technical writing.
- Regulatory compliance knowledge.
- Experience in a regulated environment, preferably in medical devices, pharmaceuticals, or nutrition.
- Two rounds of panel video interview..
